1.		When did clinical trials of candidate H1N1 influenza vaccine begin?
		NIAID announced the initiation of clinical trials on July 22, 2009.
2.		How many trials are there, and what is the purpose of these trials?
		The NIAID Vaccine and Treatment Evaluation Units (VTEU) are conducting five clinical trials of two candidate H1N1 influenza vaccines. The trials are designed to answer three primary questions: Are these vaccines safe in healthy people of various ages? How large a vaccine dose, and how many doses of vaccine, are needed to induce an immune response that is predictive of protection? Can 2009 H1N1 influenza vaccine be safely administered at the same time or sequentially with the seasonal flu vaccine, and will both vaccines induce protective immune responses?
3.		What are the Vaccine and Treatment Evaluation Units?
		The VTEUs were established by the National Institute of Allergy and Infectious Diseases in 1962. They provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases. An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into vaccine trials and to immunize the volunteers in a safe, effective, and efficient manner. This rapid-response capability is especially important for testing vaccines for emerging public health concerns such as 2009 H1N1 influenza.
4.		How many VTEUs are there, and where are they located?
		There are currently eight VTEUs located at the following sites: Baylor College of Medicine, Houston Children’s Hospital Medical Center, Cincinnati Emory University, Atlanta Group Health Cooperative, Seattle Saint Louis University, St. Louis University of Iowa, Iowa City University of Maryland School of Medicine, Baltimore Vanderbilt University, Nashville
5.		What trials are being initiated to evaluate candidate 2009 H1N1 influenza vaccines?
		The VTEUs are conducting an initial set of five clinical trials of candidate 2009 H1N1 influenza vaccines. Three of these trials are enrolling healthy adult (18 to 64 years old) and elderly (65 years and older) volunteers.  After careful review of initial safety data from over 500 adults in the first three trials, two additional trials of similar design began in children in mid-August.
6.		How do I find out more information about the VTEU trials?
		Detailed information about the trials is available from the NIH www.clinicaltrials.gov Web site. Listed below are the specific links for the initial group of five VTEU trials. Trial comparing two different strengths (15 microgram versus 30 microgram) and one versus two doses of sanofi pasteur candidate 2009 H1N1 influenza vaccine in healthy adults (18 to 64 years old) and healthy elderly adults (65 years and older). Each of the four groups in this trial will enroll up to 100 volunteers, for a target number of 400 volunteers who will receive the candidate vaccine. An additional 50 volunteers will receive an inactive (placebo) vaccine. For more information, see NCT00943631. Trial comparing two different strengths (15 microgram versus 30 microgram) and one versus two doses of CSL Limited candidate 2009 H1N1 flu vaccine in healthy adults (18 to 64 years old) and healthy elderly adults (65 years and older). Each of the four groups in this trial will enroll up to 100 volunteers, for a target number of 400 volunteers who will receive the candidate vaccine. An additional 50 volunteers will receive an inactive (placebo) vaccine. For more information, see NCT00943488. Trial comparing two different strengths (15 microgram and 30 microgram) and one and two doses of sanofi pasteur candidate 2009 H1N1 flu vaccine in healthy children (6 months to 17 years old).  Each of the two groups in this trial will enroll up to 300 volunteers, for a target number of 600 volunteers who will receive the candidate vaccine. For more information about this trial, see NCT00944073. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine in healthy adults (18 to 64 years old) and elderly adults (65 years and older) volunteers. Each of the four groups in this trial will enroll up to 200 volunteers, for a target number of 800 volunteers who will receive the candidate H1N1 vaccine. An additional 50 volunteers will receive an inactive (placebo) vaccine and the seasonal flu vaccine. For more information, see NCT00943878. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine in primed children (children who have received two doses of seasonal vaccine in one year or are older than 9 years). Each of the four groups in this trial will enroll up to 150 children, for a target number of 600 volunteers who will receive the candidate H1N1 vaccine. For more information, see NCT00943202.
7.		Will other sites be participating in these initial five trials?
		Some of the VTEUs have sub-sites that will join with the VTEUs in conducting these trials. In addition, to allow for rapid enrollment of volunteers and expand the number of trials, NIAID may fund other sites to help the VTEUs conduct future trials of H1N1 vaccines. Those trials are currently under development.
8.		Which VTEU sites are leading the initial set of five trials?
		The lead VTEU sites for these trials are the following institutions:  University of Maryland School of Medicine VTEU (Dr. Karen Kotloff, principal investigator) will lead the two trials testing the sanofi pasteur vaccine in healthy adults, elderly, and children. University of Iowa VTEU (Dr. Pat Winokur, principal investigator) will lead the trials testing the CSL vaccine in healthy adult and elderly volunteers. Saint Louis University VTEU (Dr. Sharon Frey, principal investigator) will lead the two trials testing the H1N1 vaccines given at the same time as or sequentially with the seasonal flu vaccine in healthy adult and elderly volunteers and in children. All eight VTEUs are expected to participate in these five trials.  The priority for NIAID is to enroll these trials as quickly as possible.  In order to optimize quickly enrolling these trials, NIAID wants to maintain maximum flexibility and coverage in assigning specific sites to conduct these trials.
9.		Which candidate 2009 H1N1 influenza vaccines are being tested in the VTEU trials, and why were these two vaccines chosen?
		This initial set of five VTEU trials is testing two candidate 2009 H1N1 influenza vaccines: one made by sanofi pasteur (Swiftwater, Pennsylvania) and the other by CSL Limited (Melbourne, Australia). These two vaccines were chosen initially for the VTEU trials based on Department of Health and Human Services (HHS) projections of their initial availability and the need to determine as quickly as possible if unadjuvanted vaccines could induce potentially protective immune responses. In addition, seasonal flu vaccine made by sanofi pasteur is licensed in the United States for use in children, which meant that a candidate H1N1 influenza vaccine made by this company can be  tested in U.S. children as well.  Both vaccines are available in versions made without the preservative thimerosal.  Other candidate H1N1 influenza vaccines may be tested in future VTEU trials.
10.		How many people will be enrolled in this first set of five VTEU trials?
		This initial set of five VTEU 2009 H1N1 influenza vaccine trials will enroll up to 2,400 people. For more details about target enrollment, see the specific descriptions of the five study protocols at www.clinicaltrials.gov (specific links are available in the answer to question #5).
11.		When will results from these trials be available?
		In addition to collecting blood samples approximately 3 weeks after each vaccination, study staff will also collect samples a little over 1 week after vaccination to see if there are early indications that some individuals may already have a primed immune system. Preliminary results from these early samples in a subset of the people in these trials are expected to be available a few weeks after the trials begin.
12.		How do scientists evaluate the performance of the vaccines in these trials?
		To evaluate the immune response of the vaccines in these trials, the researchers will look at the level of antibodies induced by the vaccines in the volunteers using two assays: a hemagglutinin inhibition assay (a laboratory test used to measure the amount of antibody present in a sample by determining if the antibody inhibits influenza virus from attaching to red blood cells) and a microneutralization assay (a technique used to determine if the level of antibody in the sample inhibits the virus from infecting cells grown in the laboratory).
13.		How will the safety of volunteers in these trials be ensured?
		The VTEU study teams will be closely monitoring the health status of all volunteers for any adverse side effects. In addition, a panel of outside experts will conduct an ongoing, close review of the safety data from these trials to spot any safety concerns in real time.
14.		How do these trials fit in with the trials being done by the manufacturers?
		The five manufacturers who already produce U.S.-licensed seasonal vaccine are conducting their own 2009 H1N1 influenza vaccine trials under contract with HHS. The VTEU trials are intended to generate clinical data that may be used to inform policy decisions likely to affect the administration of the vaccines.  For example, the NIAID-supported VTEU trials are evaluating the vaccines in some populations (for example, in children) that manufacturers may not be planning to study. In addition, the trials are intended to generate data that are outside a company’s clinical development plan but that may be needed to support licensure or use of the vaccine -under Emergency Use Authorization (EUA). Issued by the U.S. Food and Drug Administration, an EUA permits either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.

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